Immersive Virtual Reality and Chronic Back Pain

NCT ID: NCT04307446

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-05-31

Brief Summary

In the proposed project the investigators will evaluate the feasibility of Immersive Virtual Reality (IVR) and assess the initial effects of IVR on symptoms, affect, and tolerance to cutaneous stimuli. In this single-arm trial, the investigators will recruit 20 adults with CBP. Prior to their IVR experience, subjects will complete multiday baseline assessments using ecological momentary assessment (EMA) methodology to establish typical levels of symptoms and affect. Afterward, in a single experimental session, they will participate in two counterbalanced IVR sessions: one 10-minute and one 20-minute. Immediately after each session the investigators will measure current symptoms and affect using valid and reliable self-report questionnaires, and we will measure changes in tolerance to cutaneous stimuli using quantitative sensory testing. We will measure symptoms and affect for 72 hours after the experimental session using EMA to determine if there is a carryover. At the completion of this study, we will continue to work with stakeholders to develop clinically relevant IVR interventions for people with CBP.

Detailed Description

Visit 1-Remote: Consent. Random assignment: Subjects will complete informed consent and data collection of baseline information (demographics, medical history, perceptions of pain, and experiences with VR), surveys on pain, Pain interference, fatigue, and affect. The investigators will also help the participant upload the EMA technology onto their personal phone or tablet. Subjects will then be randomly assigned to receive either the 10- minute IVR session first or the 20-minute IVR session first. Visit 1 will take between 45 and 60 minutes.

Multiple Baseline EMA-Remote: Visit 2 will be scheduled 1-2 weeks later. During the time between visits the investigators will use ecological momentary assessment (EMA) technology to collect multiple measures of pain, fatigue and affect. In EMA subjects respond to prompts delivered through their cell phone or tablet ("pings") with documentation of current symptoms. It is a well-recognized method to capture immediate, synchronized experiences in subjects' natural environments. During this data collection period subjects will be "pinged" 3x daily and asked to rate their current levels of pain, fatigue, and affect. Time to complete these responses will be 15 minutes.

Visit 2-In person: pre Survey/Quantitative Sensory Testing (QST); First VR visit; post Survey/QST. The investigators will collect current pain, pain interference, fatigue and affect, and Quantitative Sensory Testing (QST). QST involves cutaneous (skin) psychophysical (semi-subjective) testing to assess sensory and pain perception pathways. QST quantifies the thresholds of detection of stimuli, the perceived intensity, and the temporal summation (changes in perception over multiple applications). These pain testing procedures are widely-accepted, non-invasive, and non-tissue damaging. The investigators will complete two types QST. Mechanical Pressure Pain Thresholds (MPPTh) will be assessed using a digital pressure algometer on the right upper trapezius and right thumb MP joint. Mechanical Temporal Summation of Pain (MTSP) will be assessed using weighted pinprick stimulators. The investigators will apply a train of 10 stimuli at the rate of 1 per second on the middle finger of the right hand, and subjects will rate the painfulness of the first, fifth, and tenth stimulus. All subjects will take part in two VR experiences (10 min and 20 min) for a total of 30-minutes in VR. After each experience subjects will rate their current pain, fatigue, and affect, and the investigators will complete QST. At the end of both sessions the subjects will rate their experiences of immersion using the Igroup Presence Questionaire, engagement using the Use Engagement Scale (UES), and simulation tolerance using the Simulator Sickness Questionnaire (SSQ). The investigators will also ask a series of open-ended questions about the participant's experiences with IVR and participation in the study. These will include questions about their enjoyment, perceptions of pain, and what they liked/did not like about the IVR experience as well as questions about the burden of being in the study. Visit 2 will take 1.5 to 2 hours

Post Visit 2 EMA-Remote: Subjects will complete three more days (72 hours) of 3x a day prompts for pain, fatigue and affect.

Visit 3-In person: pre Survey/Quantitative Sensory Testing (QST); Second VR visit; post Survey/QST

Post Visit 3 EMA-Remote: Subjects will complete 2 more days (48 hours) of 3x a day prompts for pain, fatigue and affect.

Conditions

Chronic Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

10 Minutes/20 Minutes

Subject takes part in 10 minute VR experience first and 20 minute VR experience second

Group Type: EXPERIMENTAL

Immersive Virtual Reality

Intervention Type: DEVICE

Immersive Virtual Reality

20 Minutes/10 Minutes

Subject takes part in 20 minute VR experience first and 10 minute VR experience second

Group Type: EXPERIMENTAL

Immersive Virtual Reality

Intervention Type: DEVICE

Immersive Virtual Reality

Interventions

Immersive Virtual Reality

Immersive Virtual Reality

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 20 to 75 years old

2. Any Back Pain (including neck pain) that has lasted greater than 3 months due to non-cancer related injury or illness.

Exclusion Criteria

1. People with back pain primarily due to rheumatic (e.g. rheumatoid arthritis or fibromyalgia)

2. people with back pain due to central neurological disorders (e.g. stroke, multiple sclerosis, spinal cord injury)

3. has contagious disorder on the face (such as pink eye) that could be transmitted via the VR head set or has open areas on the face that would come in contact with the headset

4. had a seizure, loss of awareness, or other symptom linked to an epileptic condition

5. insufficient vision to see IVR programs

6. insufficient upper extremity coordination to operate IVR controls

7. insufficient cognitive ability to answer questionnaires or learn to use the IVR

8. unable to understand and respond to English

9. Does not own a cell phone or tablet for baseline and follow-up EMA testing.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Nancy Baker

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy Baker, ScD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UL1TR002544

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000192

Identifier Type: -

Identifier Source: org_study_id